MAUDE Adverse Event Report: NOVA BIOMEDICAL NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; GLUCOSE TEST SYSTEM

Model Number 42214

Device Problem High Readings (2459)

Patient Problem Electrolyte Imbalance (2196)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

The pt was tested at 11:45, glucose result was displayed on meter as 'hi'.According to hospital policy, for any critical glucose value (high or low), nurse is supposed to recheck result with another meter before any medical interference, and should collect blood sample to send to lab to confirm result.In this case, it appears this was not fully followed.Instead of repeating and waiting on result for confirmation, result was given to doctor; doctor used 'hi' result to order insulin.Sample type was from finger-stick (right hand middle finger).Patient is (b)(6) years of age with hypertension, diabetes mellitus and dislipidemia.No peripheral circulation issue.The test from same meter repeated (at later times) - 12:34 with result of 147 mg/dl, and 18: 45 with result of 96 mg/dl; a lab test done during this time showed a result of 182 mg/dl.After treatment with insulin, pt was observed for 10 hours and discharged in good condition with glucose valve 118 mg/dl.

• Brand Name: NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL; 200 prospect st.; waltham MA 02454
• Manufacturer Contact: paul macdonald ; 200 prospect st.; waltham, MA 02454 ; 7816473700
• MDR Report Key: 3811007
• MDR Text Key: 4386255
• Report Number: 1219029-2014-00001
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K063821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: 42214
• Device Catalogue Number: 47349
• Device Lot Number: 0312350249
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR